InsomniaNCT06614803
Study of the Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined with Slow Breathing on Insomnia
A study testing Transcutaneous vagus nerve stimulation combined slow breathing and Transcutaneous vagus nerve stimulation in people with Insomnia, run by Xidian University at 1 site in China.
Trial summary
The study recruited college students with insomnia disorders and applied transcutaneous auricular vagus nerve stimulation(taVNS) combined with slow breathing. The main aims of the study are: 1) to explore the role of this novel and effective physical therapy technique of taVNS combined with slow breathing in… Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Transcutaneous vagus nerve stimulation combined slow breathing and Transcutaneous vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age over 18 years;
- Meet the definition of insomnia in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V)；
- Has not received any psychotropic drug treatment；
- PSQI(Pittsburgh Sleep Quality Index) score>7；
- ISI(Insomnia Severity Index) score≥11；
- Signed informed consent form;
- Ability and willingness to comply with the study requirements.
Who cannot join
- There are learning or working hours that affect the circadian rhythm;
- There is abuse of alcohol, nicotine, or other substances;
- Pregnancy, breastfeeding, or plans to become pregnant;
- Damage or allergy to the selected stimulation site;
- Clinically diagnosed mental disorders and other medical conditions;
- Currently taking stimulant, hormone, or other medications that may cause insomnia and are not suitable for discontinuation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulatory Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined with Slow Breathing on Insomnia and Its Impact on Interoceptive Indicators
The study recruited college students with insomnia disorders and applied transcutaneous auricular vagus nerve stimulation(taVNS) combined with slow breathing. The main aims of the study are: 1) to explore the role of this novel and effective physical therapy technique of taVNS combined with slow breathing in regulating insomnia; 2) to investigate the relationship between the synergistic effect of taVNS and slow breathing on interoceptive indicators and their therapeutic effects.
Read the detailed description
This study conducted a randomized controlled clinical trial with an intention to enroll 80 insomnia participants. Participants were randomly assigned in a 1:1:1:1 ratio to four groups:1）taVNS combined with slow breathing group；2）taVNS with normal breathing group；3）slow breathing with sham taVNS group；4）normal breathing with sham taVNS group.The study included a one-week baseline period, a two-week treatment period, and a two-week follow-up period. During the 2-week treatment period, 20 minutes of continuous treatment was performed every evening. The stimulation parameters were set to 20Hz, 200μs, 5s ON-5s OFF and a burst frequency of 2000Hz. For taVNS combined with slow breathing group,after preparing the skin, electrodes were attached to the tragus and cymba conchae of the left ear,and under the guidance of the device\'s video, the participants were instructed to perform six slow and relaxed breaths per minute (0.1Hz), while the device delivered stimulation during the 5 seconds of exhalation.For taVNS with normal breathing group,without video guidance on the device, the participants breathed freely while receiving normal taVNS intervention.For slow breathing with sham taVNS group,the participants followed the video instructions to perform slow breathing while wearing the stimulation electrodes, but the device only outputted stimulation for one minute.For normal breathing with sham taVNS group,the device outputted stimulation for only one minute, and the participants breathed normally. EEG and ECG data were collected before and after the 2-week treatment, and scale data were collected before and after the treatment as well as at the end of follow-up. Sleep diaries were recorded throughout the 5-week period.
- Conditions
- Insomnia
- Being tested
- Transcutaneous vagus nerve stimulation combined slow breathing, Transcutaneous vagus nerve stimulation
- Keywords
- Insomnia, Interoception, Transcutaneous Auricular Vagus Nerve Stimulation, Slow Breathing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulation combined slow breathingDevice
The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs,5s ON-5s OFF,and a burst frequency of 2000Hz. Electrodes were attached to the tragus and cymba conchae of the left ear,the screen of the device displays slow breathing guidance video at 0.1Hz, while the device delivered stimulation during the 5 seconds of exhalation.
Transcutaneous vagus nerve stimulationDevice
Without slow breathing guidance video on the stimulation device,the stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs,5s ON-5s OFF,and a burst frequency of 2000Hz. Electrodes were attached to the tragus and cymba conchae of the left ear
| Study group | Role | What they receive |
|---|---|---|
| taVNS combined with slow breathing | Active comparator | For taVNS combined with slow breathing group,after preparing the skin with an alcohol pad, electrodes were attached to the tragus and cymba conchae of the left ear,and under the guidance of the device's video, the participants were instructed to perform six slow and relaxed breaths per minute (0.1Hz), while the built-in parameters of the device delivered stimulation during the 5 seconds of exhalation.The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs, and a burst frequency of 2000Hz, 5s ON-5s OFF;stimulation time:20min. Receives: Device: Transcutaneous vagus nerve stimulation combined slow breathing |
| taVNS with normal breathing | Active comparator | For taVNS with normal breathing group,without video guidance on the stimulation device, the participants breathed freely while receiving normal tVNS intervention.Electrodes were attached to the tragus and cymba conchae of the left ear. The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs, 5s ON-5s OFF, and a burst frequency of 2000Hz, ;stimulation time:20min. Receives: Device: Transcutaneous vagus nerve stimulation |
| slow breathing with sham taVNS | Active comparator | For slow breathing with sham taVNS group,the participants followed the video instructions to perform slow breathing while wearing the stimulation electrodes, but the device only outputted stimulation for one minute and then stopped. Receives: Device: Transcutaneous vagus nerve stimulation combined slow breathing |
| normal breathing with sham taVNS | Sham comparator | For normal breathing with sham taVNS group,the device were set to output stimulation for only one minute and then stop, and the participants breathed normally Receives: Device: Transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep diary indicators after two weeks of treatment
Sleep latency, sleep efficiency, wake time after sleep onset, number of wake times after sleep onset, and total sleep time were used as the primary outcome measure in the sleep diary.
Measured: Sleep diaries were collected daily for five weeks, but changes in sleep diary data were assessed after one week baseline, two weeks of treatment, and two weeks of follow-up.
Secondary outcomes (7)
Changes in heart rate variability
Heart rate variability(HRV) were analyzed to evaluate the mean peak interval (MeanRR) of the RR and three commonly used measures of autonomic nervous function: the root mean square sum of the difference between adjacent normal heartbeat intervals (RMSSD), the percentage of adjacent NN differences greater than 50ms in the total number of sinus heart beats (PNN 50%), and high frequency power (aHF).
Measured: Heart rate variability will be assessed twice within five weeks:at baseline,and after two weeks of treatment.
Changes in heartbeat evoked potential
Heartbeat evoked potential(HEP) is the electrical activity of the brain at a specific moment in the heart cycle, which is synchronized with the R wave of the heart's electrical signals and can be measured by recording the electrical activity of the brain at a specific point in time within the heartbeat cycle. HEP represents an electrophysiological marker of cortical processing of incoming cardiovascular information.
Measured: Heartbeat evoked potential will be assessed twice within five weeks:at baseline,and after two weeks of treatment.
Changes in ISI scores
The Insomnia Severity Index (ISI) is utilized to assess the severity of insomnia and its impact on physical health, daily function, and quality of life. This scale includes seven items, with a total scoring range from 0 to 28. Higher scores denote more severe insomnia. The change in ISI score will be determined by subtracting the baseline score from the score at each subsequent time point.
Measured: ISI will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Changes in PSQI scores
The Pittsburgh Sleep Quality Index(PSQI) assessed the sleep quality of the participants in the last 1 month, which was composed of 19 self-rated items and 5 other rated items, in which the 19th self-rated items and 5 other rated items did not participate in the score. The 18 self-rated entries that participate in the scoring can be combined into seven sections. They were: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, hypnotic drug use and daytime dysfunction. Each part is scored from 0 to 3, and the cumulative score of each part is divided into PSQI total score, ranging from 0 to 21, and the higher the score, the worse the sleep quality
Measured: PSQI will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Change in PHQ-9 scores
The Patient Health Questionnaire-9 (PHQ-9) encompasses nine items, each representing a different facet of depressive symptoms. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. The change in PHQ-9 score will be determined by subtracting the baseline score from the score at each subsequent time point.
Measured: PHQ-9 will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Change in GAD-7 scores
The Generalized Anxiety Disorder Scale (GAD-7) is used to assess the emotional state of patients. The Generalized Anxiety Disorder Scale (GAD-7) comprises seven items, with a total possible score ranging from 0 to 21. An elevated score suggests a more pronounced level of anxiety. The change in GAD-7 score will be determined by subtracting the baseline score from the score at each subsequent time point.
Measured: GAD-7 will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Change in FFS scores
The Flinders Fatigue Scale(FFS) consists of seven entries that measure various fatigue characteristics (e.g., frequency, severity) experienced during the past two weeks. Six items were presented in Likert form, with responses ranging from 0(not at all) to 4(very serious). The total score is calculated by the sum of all the items. The total score of the scale ranges from 0 to 31 points, and the higher the score, the more serious the fatigue degree of patients.
Measured: FFS will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Jan 2024
- Primary completion14 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xidian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Wei, Phd, Principal investigator, Xidian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614803
- Sponsor's protocol ID
- 20240731
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined with Slow Breathing on Insomnia and Its Impact on Interoceptive Indicators
- ClinicalTrials.gov ID
- NCT06614803
- Acronym / sponsor ID
- 20240731
- Conditions
- Insomnia
- Keywords
- Insomnia, Interoception, Transcutaneous Auricular Vagus Nerve Stimulation, Slow Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Xidian UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study recruited college students with insomnia disorders and applied transcutaneous auricular vagus nerve stimulation(taVNS) combined with slow breathing. The main aims of the study are: 1) to explore the role of this novel and effective physical therapy technique of taVNS combined with slow breathing in regulating insomnia; 2) to investigate the relationship between the synergistic effect of taVNS and slow breathing on interoceptive indicators and their therapeutic effects.
Detailed description
This study conducted a randomized controlled clinical trial with an intention to enroll 80 insomnia participants. Participants were randomly assigned in a 1:1:1:1 ratio to four groups:1）taVNS combined with slow breathing group；2）taVNS with normal breathing group；3）slow breathing with sham taVNS group；4）normal breathing with sham taVNS group.The study included a one-week baseline period, a two-week treatment period, and a two-week follow-up period. During the 2-week treatment period, 20 minutes of continuous treatment was performed every evening. The stimulation parameters were set to 20Hz, 200μs, 5s ON-5s OFF and a burst frequency of 2000Hz. For taVNS combined with slow breathing group,after preparing the skin, electrodes were attached to the tragus and cymba conchae of the left ear,and under the guidance of the device\'s video, the participants were instructed to perform six slow and relaxed breaths per minute (0.1Hz), while the device delivered stimulation during the 5 seconds of exhalation.For taVNS with normal breathing group,without video guidance on the device, the participants breathed freely while receiving normal taVNS intervention.For slow breathing with sham taVNS group,the participants followed the video instructions to perform slow breathing while wearing the stimulation electrodes, but the device only outputted stimulation for one minute.For normal breathing with sham taVNS group,the device outputted stimulation for only one minute, and the participants breathed normally. EEG and ECG data were collected before and after the 2-week treatment, and scale data were collected before and after the treatment as well as at the end of follow-up. Sleep diaries were recorded throughout the 5-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| taVNS combined with slow breathing | Active comparator | Device: Transcutaneous vagus nerve stimulation combined slow breathingFor taVNS combined with slow breathing group,after preparing the skin with an alcohol pad, electrodes were attached to the tragus and cymba conchae of the left ear,and under the guidance of the device's video, the participants were instructed to perform six slow and relaxed breaths per minute (0.1Hz), while the built-in parameters of the device delivered stimulation during the 5 seconds of exhalation.The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs, and a burst frequency of 2000Hz, 5s ON-5s OFF;stimulation time:20min. |
| taVNS with normal breathing | Active comparator | Device: Transcutaneous vagus nerve stimulationFor taVNS with normal breathing group,without video guidance on the stimulation device, the participants breathed freely while receiving normal tVNS intervention.Electrodes were attached to the tragus and cymba conchae of the left ear. The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs, 5s ON-5s OFF, and a burst frequency of 2000Hz, ;stimulation time:20min. |
| slow breathing with sham taVNS | Active comparator | Device: Transcutaneous vagus nerve stimulation combined slow breathingFor slow breathing with sham taVNS group,the participants followed the video instructions to perform slow breathing while wearing the stimulation electrodes, but the device only outputted stimulation for one minute and then stopped. |
| normal breathing with sham taVNS | Sham comparator | Device: Transcutaneous vagus nerve stimulationFor normal breathing with sham taVNS group,the device were set to output stimulation for only one minute and then stop, and the participants breathed normally |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age over 18 years;
- Meet the definition of insomnia in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V)；
- Has not received any psychotropic drug treatment；
- PSQI(Pittsburgh Sleep Quality Index) score>7；
- ISI(Insomnia Severity Index) score≥11；
Key exclusion criteria (6 listed)
- There are learning or working hours that affect the circadian rhythm;
- There is abuse of alcohol, nicotine, or other substances;
- Pregnancy, breastfeeding, or plans to become pregnant;
- Damage or allergy to the selected stimulation site;
- Clinically diagnosed mental disorders and other medical conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagus nerve stimulation combined slow breathingThe stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs,5s ON-5s OFF,and a burst frequency of 2000Hz. Electrodes were attached to the tragus and cymba conchae of the left ear,the screen of the device displays slow breathing guidance video at 0.1Hz, while the device delivered stimulation during the 5 seconds of exhalation. | Device | slow breathing with sham taVNS, taVNS combined with slow breathing |
| Transcutaneous vagus nerve stimulationWithout slow breathing guidance video on the stimulation device,the stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs,5s ON-5s OFF,and a burst frequency of 2000Hz. Electrodes were attached to the tragus and cymba conchae of the left ear | Device | normal breathing with sham taVNS, taVNS with normal breathing |
Primary outcome
Sleep diary indicators after two weeks of treatment
Time frame: Sleep diaries were collected daily for five weeks, but changes in sleep diary data were assessed after one week baseline, two weeks of treatment, and two weeks of follow-up.
Sleep latency, sleep efficiency, wake time after sleep onset, number of wake times after sleep onset, and total sleep time were used as the primary outcome measure in the sleep diary.
7 secondary outcomes
Changes in heart rate variability
Time frame: Heart rate variability will be assessed twice within five weeks:at baseline,and after two weeks of treatment.
Changes in heartbeat evoked potential
Time frame: Heartbeat evoked potential will be assessed twice within five weeks:at baseline,and after two weeks of treatment.
Changes in ISI scores
Time frame: ISI will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Changes in PSQI scores
Time frame: PSQI will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Change in PHQ-9 scores
Time frame: PHQ-9 will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Change in GAD-7 scores
Time frame: GAD-7 will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Change in FFS scores
Time frame: FFS will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qin Wei, Phd principal investigator
Xidian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagus nerve stimulation combined slow breathing and Transcutaneous vagus nerve stimulation in people with Insomnia, run by Xidian University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep diary indicators after two weeks of treatment (time frame: Sleep diaries were collected daily for five weeks, but changes in sleep diary data were assessed after one week baseline, two weeks of treatment, and two weeks of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.